Registration Dossier

Administrative data

Description of key information

Rat acute oral and dermal LD50 values were > 2000 mg/kg.  No mortalities were observed in either study.  Severe irritation/corrosion was observed in the acute dermal study. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Quality of whole database:
The acute rat oral LD50 was determined to be > 2000 mg/kg of body weight.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
2 000 mg/kg bw

Additional information

Rat acute oral and dermal LD50 values were > 2000 mg/kg for the test substance Formaldehyde, polymer with 1,3 -benzenedimethanamine and phenol. No adverse systemic effects were observed in either study. However, following the 24 hr dermal exposure evidence of severe skin irriation and corrosion were observed.


Justification for selection of acute toxicity – oral endpoint
Mortality is the standard end-point for acute studies. No other adverse effects were observed in the rat acute oral study.

Justification for selection of acute toxicity – inhalation endpoint
Study not required.

Justification for selection of acute toxicity – dermal endpoint
Severe dermal irritation was observed.

Justification for classification or non-classification

With acute oral and dermal rat LD50 values of > 2000 mg/kg of body weight, Classification and Labeling for acute toxic effects is not required.